Spray Dried Plasma Cholesterol Crystal Reduction
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Solution Overview
Problem
Current methods for drying blood plasma, such as freeze drying, result in cholesterol crystals, alkalotic pH, and logistical issues with storage and rehydration, making them unsuitable for emergency transfusions, especially in remote or battlefield settings where rapid and reliable access to plasma is critical.
Innovation Solution
The development of spray dried plasma with particles sized between 1 and 7 microns, reduced cholesterol crystals, stable residual moisture, and reconstitution with Sterile Water For Injection (SWFI) to achieve a near-normal pH and protein functionality, allowing for rapid rehydration and storage at various temperatures.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Duration of action of stationary object
If freeze drying is used to dry blood plasma, then long-term storage is achieved, but cholesterol crystals form and pH becomes alkalotic
Solution Approach 1:
The patent changes the drying parameters by using spray drying at controlled temperatures (inlet temperature 80-150°C, outlet temperature 40-80°C) with specific residence times to produce amorphous particles that prevent cholesterol crystallization while maintaining near-neutral pH upon reconstitution
Solution Approach 2:
The patent utilizes the phase transition of water from liquid to vapor during spray drying to rapidly dehydrate plasma droplets, creating a glassy amorphous matrix that traps cholesterol molecules and prevents crystal formation, while the controlled drying kinetics preserve protein functionality
2Reliability
If freeze dried plasma is stored in glass bottles, then product protection is achieved, but weight increases and handling becomes difficult
Solution Approach 1:
The patent employs single-use sterile containers made of lightweight materials such as plastic or aluminum instead of traditional glass bottles, reducing weight and breakage risk while maintaining sterility and product protection through integrated sterile barriers and seals
Solution Approach 2:
The patent uses flexible sterile barriers and thin-film containers that provide adequate protection against contamination and degradation while significantly reducing weight and improving portability compared to rigid glass bottles
3Loss of time
If rapid rehydration is performed with glass bottle vent system, then time is reduced, but rehydration fluid may be added too quickly causing problems
Solution Approach 1:
The patent removes the complex vent system from glass bottles and replaces it with a simplified cap design that includes integrated pressure equalization features, eliminating the risk of uncontrolled fluid addition while maintaining rapid rehydration capability
Solution Approach 2:
The patent incorporates self-regulating features in the cap design such as pressure-sensitive vents or air-gaps that automatically control the rehydration rate by allowing air to escape at a controlled rate, eliminating the need for manual venting and preventing uncontrolled fluid addition
4Speed
If spray drying is used to create small particles, then rehydration speed is improved, but particle size control becomes critical
Solution Approach 1:
The patent employs dynamic control of spray drying parameters including variable inlet temperature, adjustable aerosolization pressure, and controlled residence time in the drying chamber to optimize particle size distribution and ensure consistent rehydration performance
Solution Approach 2:
The patent implements feedback control mechanisms to monitor and adjust spray drying parameters in real-time, using particle size sensors or flow measurement to maintain optimal particle characteristics and compensate for variations in feed rate or environmental conditions
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The spray dried plasma is stable for up to 26 hours post-reconstitution, maintains protein functionality, and can be stored for extended periods, addressing the limitations of existing methods by reducing cholesterol crystals and improving storage and rehydration logistics.
Implementation Method 1
spray dried plasma... residual moisture in a range between about 0.5% and about 2.5%
Implementation Method 2
reconstitution with Sterile Water For Injection (SWFI) to achieve a near-normal pH and protein functionality
Data Source
AI summary
The present invention relates to a spray dried plasma composition having one or more of the following characteristics: when reconstituted, largely amorphous and has no cholesterol crystals; when reconstituted, the mean size of large particulates is reduced; has low residual moisture; reconstitutes rapidly in under four minutes; highly stable when stored under refrigeration, at room temperature or at elevated temperatures and allows for storage for longer periods of time; when reconstituted, exhibits recovery of the most fragile of proteins, including von Willebrand's factor; when reconstituted with Sterile Water for Injection (SWFI), reconstituted plasma is at a pH that is near normal plasma pH, and does so without treatment or storage in CO2 or other pH adjustment.